ANDA 075233

MYLAN TECHNOLOGIES

FDA Drug Application

Application #075233

Documents

• Review: 2000-02-24
• Letter: 2000-02-24

Application Sponsors

ANDA 075233

MYLAN TECHNOLOGIES

Marketing Status

• Prescription: 001

Application Products

001

FILM, EXTENDED RELEASE; TRANSDERMAL

0.05MG/24HR

0

ESTRADIOL

ESTRADIOL

FDA Submissions

	ORIG	1	AP	2000-02-24
LABELING; Labeling	SUPPL	2	AP	2001-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-12-23
LABELING; Labeling	SUPPL	7	AP	2005-01-06
LABELING; Labeling	SUPPL	9	AP	2005-01-21
LABELING; Labeling	SUPPL	10	AP	2005-03-04
LABELING; Labeling	SUPPL	11	AP	2005-10-06
LABELING; Labeling	SUPPL	12	AP	2006-07-24

Submissions Property Types

ORIG	1	Null	29
SUPPL	3	Null	0
SUPPL	4	Null	0

TE Codes

001

Prescription

AB2

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75233
            [companyName] => MYLAN TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.05MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE; TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.05MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE; TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)